Tag Archives: Abbreviated New Drug Application (ANDA)

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court explained that a novel product with unexpected advantageous properties is not obvious just because the process by which it was made might have … Continue reading this entry

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and remanded for entry of judgment in favor of Braintree. In reaching its decision, the court held Breckenridge to its previous stipulations, and found that proposed ANDA labeling … Continue reading this entry

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so doing, the court emphasized the narrow scope of the Norian exception to the “closed” nature of “consisting of” language that … Continue reading this entry

On Sale Bar Invalidates Safyral, Beyaz Folate Patent

In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate patent at issue. Despite the confidentiality agreement that was in place, a footnote in the court’s opinion indicates that it was … Continue reading this entry

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the state at issue–were sufficient “personal contacts” to give rise to specific personal jurisdiction.… Continue reading this entry

Obviousness Versus Obviousness-Type Double Patenting

In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding obviousness-type double patenting. Is the court blurring the line between these doctrines? … Continue reading this entry

Divided Infringement Between Doctor And Patient

Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the pharmaceutical context, where a patient self-administers a drug. In Eli Lilly and Company v. Teva Parenteral Medicines, Inc., … Continue reading this entry

Lumigan Patents Upheld By Unexpected Results

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still possible to defend a patent to a pharmaceutical formulation, at least when it is associated with truly unexpected results. … Continue reading this entry

Patent Safe Harbor Applies To Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for patent infringement when the activities generated information that was submitted to the FDA to support a supplemental New Drug Application and … Continue reading this entry

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for delay” settlements). Although the court’s decision interprets state antitrust laws, it may influence other states applying similarly … Continue reading this entry

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent such that there can be no infringement as a matter of law. The court reached this decision because only … Continue reading this entry

Federal Circuit Finds Apotex ANDAs Do Not Infringe Lysteda Patents

In two decisions issued under the same name (Ferring B.V. v. Watson Laboratories, Inc.), the Federal Circuit upheld the validity of the Orange Book-listed patents for Lysteda®, but found that they were not infringed by either Apotex’s or Watson’s Abbreviated New Drug Applications (ANDAs). In this article, I focus on the decision relating to the Apotex ANDAs, and … Continue reading this entry

Federal Circuit Finds That FDA Citizen Petition Could Give Rise To Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge Newman wrote a dissenting opinion warning against the chilling effect that antitrust liability could have on a citizen’s right to communicate with … Continue reading this entry

Federal Circuit Looks For A Different Kind Of Unexpected Results In BMS v. Teva

In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to unexpected results characterized as reflecting a difference in “degree” rather than a difference in “kind.” This decision joins other recent Federal Circuit … Continue reading this entry

Federal Circuit Vacates Infringement Of Braintree SUPREP Patent

In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of infringement to remand for further factual findings. When no judge agrees with the basis of the decision and neither party is satisfied … Continue reading this entry

Federal Circuit Affirms Validity Of Tarka Patent On Combination Pharmaceutical Product

The Federal Circuit decision in Sanofi-Aventis Deutschland GmbH v. Glenmark Pharmaceuticals Inc., USA, addresses several interesting issues, but is most likely to be cited by other patent holders for its affirmance of the jury verdict that upheld the Tarka patent at issue. The jury found that claims directed to a pharmaceutical composition comprising a combination … Continue reading this entry

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable based on the Federal Circuit s recounting of the prior art, but the court’s willingness to affirm invalidity on summary judgment where the record included … Continue reading this entry

Federal Circuit Finds LUNESTA Patent Infringement Based On ANDA Product Description Not Avoided By Other Certifications

In Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reversed the district’s holding of no Lunesta® patent infringement that was based on a certification submitted to the court, and found infringement based on the product described in the Abbreviated New Drug Application (ANDA). In reaching its decision, the court upheld the district … Continue reading this entry